BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MLX 300W XENON LIGHTSOURCE

    MDR report key: 6016577 · Received October 11, 2016

    Report

    Report Number
    2523190-2016-00169
    Event Type
    Malfunction
    Date Received
    October 11, 2016
    Date of Event
    September 13, 2016
    Report Date
    September 12, 2016
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    FCW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON 9/28/2016 INTEGRA INVESTIGATION COMPLETED. METHOD: FAILURE ANALYSIS, DEVICE HISTORY EVALUATION RESULTS: FAILURE ANALYSIS - A VISUAL INSPECTION FOUND NO VISIBLE. EXTERNAL PHYSICAL DAMAGE. INTERNAL INSPECTION FOUND THE FAN TO THE LAMP WAS UNPLUGGED. IN ADDITION, THE BLACK LAMP HOUSING WAS MELTED AT THE BASE. FUNCTIONAL TESTING FOUND THE LAMP WAS OPERATIONAL. NOTE THAT WITHOUT THE FAN(S) BEING OPERATIONAL THE AMBIENT TEMPERATURE IN THE MLX WILL INCREASE INCLUDING THE OPERATING TEMPERATURE OF THE LAMP. THIS CONDITION COULD RESULT IN THE LAMP OVERHEATING AND MELTING THE HOUSING. REPLACED LAMP TO RESOLVE THE REPORTED COMPLAINT. DEVICE HISTORY EVALUATION - NONCONFORMING PRODUCT REPORT / NONCONFORMING MATERIAL REPORT HISTORY INDICATES: 1PC BURNT AND SMOKED. NCMRS ISSUED: UNIT EMITS A STRONG ELECTRICAL ODOR WHEN POWER IS ON LAMP AND ILLUMINATED. VARIANCE AUTHORIZATION / DEVIATION HISTORY: NONE ENGINEERING CHANGE ORDER/MANUFACTURING CHANGE ORDER HISTORY: THERE IS NO APPLICABLE ENGINEERING CHANGE ORDER/MANUFACTURING CHANGE ORDER HISTORY. CONCLUSION: THE COMPLAINT REPORT OF "HEADLIGHT (LIGHT SOURCE) IS SMOKING AND WARM" HAS BEEN CONFIRMED. THE UNIT WAS REPAIRED AND RETURNED TO THE CUSTOMER. NO MANUFACTURING, WORKMANSHIP, OR MATERIAL DEFICIENCY HAS BEEN IDENTIFIED.

    Description of Event or Problem · 1

    CUSTOMER INITIALLY REPORTS THAT THE "HEADLIGHT IS SMOKING. BURNING SMELL - WARM TO TOUCH." FOUND COMPONENT LOOSE IN UNIT. ON 9/23/2016 CUSTOMER CONFIRMS NO PATIENT INJURY, NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669468 MLX 300W XENON LIGHTSOURCE N/A FCW INTEGRA YORK, PA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1